We will form a Human Subjects and Biostatistics Core. The Biostatistics Component is the same Core Unit that has been collaborating with this Research Center over the last 21 years. The Human Subjects Component is new to the Otitis Media Research Center, with past services being incorporated in existing projects. The two components, Biostatistics and Human Subjects, could form two separate Cores; however, they both provide services in data management and support to help the investigators complete and enhance their existing aims and explore future research directions. By combining into one Core Unit we will also ensure that the various project databases will receive enough supervision from biostatisticians. To staff this combined core unit, we have assembled a team of highly qualified investigators. In Biostatistics Dr. Le, Mr. Lindgren, and a graduate research assistant have expertise in the design of pilot studies, design and management of clinical trials and surveys, database development, data processing, and statistical analysis. In Human Subjects Dr. Daly, Ms. Knox, and a graduate research assistant will continue to provide services to yield data of consistently high quality for existing projects, enhancing the ability of these individual projects to complete their specific aims and explore new related aims. A unique feature of the Core will be the provision of pilot data for new projects drawing from databases and participants from previous OM studies. The mission of the Human Subjects and Biostatistics Core is to support and promote high quality otitis media research. This core is responsible for assisting the PIs in study design, data collection and processing, quality control, data storage and retrieval, and data analysis of all studies, so as to provide all investigators with a high level and broad range of expertise in data quality, management and data analysis. The key areas are quality control and standardization of data analyses.